Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders (ANRS VITAVIC)

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ClinicalTrials.gov Identifier: NCT01226446

Recruitment Status :
Completed

First Posted : October 22, 2010

Last Update Posted : August 11, 2014

Sponsor:

French National Agency for Research on AIDS and Viral Hepatitis

Information provided by (Responsible Party):

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )

Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy

Condition or disease

Intervention/treatment

Phase

Chronic Hepatitis C

Drug: vitamin D

Phase 2

Detailed Description:

An open-label, prospective evaluation of the efficacy of vitamin D supplementation starting 1 month before and continuing for the duration of combination therapy with pegylated interferon alpha (2a or 2b) plus ribavirin in patients with chronic viral hepatitis C genotype 1 or 4, nonresponders to a first antiviral therapy.Vitamin D supplementation is started one month before antiviral therapy in order to introduce pegylated interferon plus ribavirin in patients with optimal vitamin D status

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Chronic Hepatitis C Genotype 1 or 4

Hypovitaminosis D defined by a value <30 ng / ml

Patient non responder to previous antiviral combination therapy of Pegylated Interferon and Ribavirin defined by a decrease in viral load <2 log at week 12 of the first course (Peg/RBV)

Patient who received at least 80% of the optimal dose of Pegylated Interferon and Ribavirin according to current recommendations

Patient for which the investigating physician decided to initiate treatment for hepatitis C combination therapy